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The goal of this clinical trial is to research whether different methods of suturing during elective cesarean delivery affect surgery time and early wound healing. The study includes adults undergoing elective cesarean delivery with subcutaneous fat thickness of at least 2 centimetres.
The main questions it aims to answer are:
The investigators will compare three approaches-no subcutaneous suturing, three interrupted sutures, and one continuous non-locking suture-to research if one method improves wound outcomes without meaningfully increasing operative time.
Participants will:
Receive one of the three closure methods during their cesarean delivery Return around day ten after surgery for a standardised wound examination and an ultrasound evaluation of the incision area.
Postoperative wound morbidity after cesarean delivery, while relatively infrequent, contributes to maternal discomfort, delayed recovery, and increased health care utilization. Subcutaneous tissue management at closure is a potentially modifiable surgical step, and both the decision to approximate the subcutaneous layer and the suturing technique may influence early wound outcomes as well as operative efficiency. However, consensus is lacking regarding the optimal approach.
This prospective comparative study evaluates three standardized subcutaneous tissue closure strategies among adults undergoing elective cesarean delivery via Pfannenstiel incision with a subcutaneous adipose tissue thickness of at least two centimeters: (one) no subcutaneous suturing, (two) closure with three interrupted sutures, and (three) closure with a continuous non-locking single-layer suture. Participants are assigned in equal numbers to each strategy using a predefined sequential allocation based on operative order. The surgical technique and follow-up assessments are conducted according to a predefined protocol, and participants are blinded to group assignment.
The study focuses on two clinically relevant domains: operative duration and short-term wound outcomes. Operative efficiency is assessed using total surgery duration. Wound outcomes are assessed around postoperative day ten using both standardized clinical incision assessment (including signs suggestive of infection such as erythema, warmth, discharge, dehiscence, or separation) and incision-site ultrasonography to identify subcutaneous fluid collection and other wound-related findings. By comparing these commonly used closure strategies under standardized conditions, the study aims to determine whether subcutaneous closure technique meaningfully affects operative time and early wound morbidity following elective cesarean delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous Closure (No Suturing) | No Intervention | Participants undergo elective cesarean delivery with no subcutaneous closure prior to skin closure. | |
| Interrupted Subcutaneous Closure (Three Interrupted Sutures) | Experimental | Participants undergo elective cesarean delivery with subcutaneous suturing using three interrupted sutures before skin closure. |
|
| Continuous Non-locking Subcutaneous Closure (Single-layer Continuous Suture) | Experimental | Participants undergo elective cesarean delivery with single-layer subcutaneous tissue suturing using a continuous, non-locking suture technique prior to skin closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture technique, Interrupted closure (3 sutures) | Other | Interrupted closure (3 sutures): Subcutaneous adipose tissue is sutured with three interrupted sutures placed along the incision before routine skin closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall wound complications by postoperative day 10 | Proportion of participants with any wound complication at day 10, defined as any abnormal incision-site ultrasonography finding (e.g., subcutaneous fluid collection/seroma, hematoma, abscess, cavity formation) and/or clinical wound infection findings on standardized exam (e.g., discharge, dehiscence, erythema, warmth). Outcome is recorded as present vs absent. | Postoperative day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative duration | Total surgery duration recorded in minutes (operative time). | Day of surgery (intraoperative) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Yuzuncu Yil University | Van | Tuşba | 65090 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33212324 | Background | Carbonnel M, Brot D, Benedetti C, Kennel T, Murtada R, Revaux A, Ayoubi JM. Risks factors FOR wound complications after cesarean section. J Gynecol Obstet Hum Reprod. 2021 Sep;50(7):101987. doi: 10.1016/j.jogoh.2020.101987. Epub 2020 Nov 16. | |
| 28176441 | Background | Pergialiotis V, Prodromidou A, Perrea DN, Doumouchtsis SK. The impact of subcutaneous tissue suturing at caesarean section on wound complications: a meta-analysis. BJOG. 2017 Jun;124(7):1018-1025. doi: 10.1111/1471-0528.14593. Epub 2017 Apr 1. |
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De-identified individual participant data will be shared with qualified researchers upon reasonable request after publication of the primary results, subject to approval by the study team and completion of a data use agreement, to protect participant confidentiality.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2026 |
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| Suture technique, Continuous non-locking closure | Other | Continuous non-locking closure: Subcutaneous adipose tissue is approximated with a single-layer continuous, non-locking running suture along the incision before routine skin closure. |
|
| Feb 27, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013536 | Suture Techniques |
| ID | Term |
|---|---|
| D058106 | Wound Closure Techniques |
| D013514 | Surgical Procedures, Operative |
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